InsomniaPhase 2NCT00748592
A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia
A Phase 2 study testing PD 0200390 in people with Insomnia, run by Pfizer.
Trial summary
This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5 mg, 15 mg and 30 mg or placebo) daily 30… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- PD 0200390
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 3 month history of primary insomnia
- Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)
Who cannot join
- Any history of psychiatric diagnosis
- History or presence of any breathing related sleep disorder
- History or presence of any medical or neurological condition that could interfere with sleep
- Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week
About this study
Official title: PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover, Multicenter Polysomnography Trial Of PD 0200390 In Elderly Subjects With Primary Insomnia
This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5 mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a polysomnography (PSG) lab.
- Conditions
- Insomnia
- Being tested
- Placebo, PD 0200390
- Keywords
- Insomnia, Primary Insomnia, Chronic Insomnia, DIMS (Disorders of Initiating and Maintaining Sleep), Disorders of Initiating and Maintaining Sleep
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Subjects in this arm will be administered 3 capsules of placebo 30 minutes before bedtime for two consecutive nights in the sleep lab.
PD 0200390Drug
Subjects in this arm will be administered 3 capsules totaling 5 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
PD 0200390Drug
Subjects in this arm will be administered 3 capsules totaling 15 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
PD 0200390Drug
Subjects in this arm will be administered 3 capsules totaling 30 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| PD 0200390, 5 mg | Experimental | Not described Receives: Drug: PD 0200390 |
| PD 0200390, 15 mg | Experimental | Not described Receives: Drug: PD 0200390 |
| PD 0200390, 30 mg | Experimental | Not described Receives: Drug: PD 0200390 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wake After Sleep Onset (WASO) as determined by PSG assessment
Measured: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Secondary outcomes (15)
Sleep and early morning behavior as determined by Leeds Sleep Evaluation Questionnaire (LSEQ)
Measured: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Latency to persistent sleep (LPS) as determined by PSG assessment
Measured: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Latency to REM Sleep as determined by PSG assessment
Measured: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Sleep efficiency (SE) as determined by PSG assessment
Measured: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Number of awakenings after sleep onset (NAASO) as determined by PSG assessment
Measured: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Total wake time (TWT) as determined by PSG assessment
Measured: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Next day sleepiness as determined by Visual Analog Scale (VAS) for Sleepiness
Measured: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Number of arousals as determined by PSG assessment
Measured: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Total sleep time (TST) as determined by PSG assessment
Measured: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Next day performance sa determined by Digit Symbol Substitution Test (DSST)
Measured: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Subjective Sleep Onset and Maintenance as determined by Subjective Sleep Questionnaire (SSQ)
Measured: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Wake time during sleep (WTDS) as determined by PSG assessment
Measured: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Wake time after sleep (WTAS) as determined by PSG assessment
Measured: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Percentages of Stage 1 Sleep, Stage 2 Sleep, Stage 3+4 Sleep, Stage REM Sleep as determined by PSG assessment
Measured: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Restorative sleep as determined by Restorative Sleep Questionnaire Daily (RSQ D)
Measured: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startJan 2009
- Primary completionJun 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748592
- Sponsor's protocol ID
- A4251026
- Status last verified
- Feb 2009
- First submitted
- 5 Sep 2008
- Last updated
- 12 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD 0200390 Dose-Ranging Trial: A Randomized, Double-Blind, Placebo-Controlled, 4-Way Crossover, Multicenter Polysomnography Trial Of PD 0200390 In Elderly Subjects With Primary Insomnia
- ClinicalTrials.gov ID
- NCT00748592
- Acronym / sponsor ID
- A4251026
- Conditions
- Insomnia
- Keywords
- Insomnia, Primary Insomnia, Chronic Insomnia, DIMS (Disorders of Initiating and Maintaining Sleep), Disorders of Initiating and Maintaining Sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 8 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5 mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a polysomnography (PSG) lab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| PD 0200390, 5 mg | Experimental | Drug: PD 0200390 |
| PD 0200390, 15 mg | Experimental | Drug: PD 0200390 |
| PD 0200390, 30 mg | Experimental | Drug: PD 0200390 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 3 month history of primary insomnia
- Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)
Key exclusion criteria (4 listed)
- Any history of psychiatric diagnosis
- History or presence of any breathing related sleep disorder
- History or presence of any medical or neurological condition that could interfere with sleep
- Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSubjects in this arm will be administered 3 capsules of placebo 30 minutes before bedtime for two consecutive nights in the sleep lab. | Drug | Placebo |
| PD 0200390Subjects in this arm will be administered 3 capsules totaling 5 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab. | Drug | PD 0200390, 5 mg |
| PD 0200390Subjects in this arm will be administered 3 capsules totaling 15 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab. | Drug | PD 0200390, 15 mg |
| PD 0200390Subjects in this arm will be administered 3 capsules totaling 30 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab. | Drug | PD 0200390, 30 mg |
Primary outcome
Wake After Sleep Onset (WASO) as determined by PSG assessment
Time frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
15 secondary outcomes
Sleep and early morning behavior as determined by Leeds Sleep Evaluation Questionnaire (LSEQ)
Time frame: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Latency to persistent sleep (LPS) as determined by PSG assessment
Time frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Latency to REM Sleep as determined by PSG assessment
Time frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Sleep efficiency (SE) as determined by PSG assessment
Time frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Number of awakenings after sleep onset (NAASO) as determined by PSG assessment
Time frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Total wake time (TWT) as determined by PSG assessment
Time frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Next day sleepiness as determined by Visual Analog Scale (VAS) for Sleepiness
Time frame: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Number of arousals as determined by PSG assessment
Time frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Total sleep time (TST) as determined by PSG assessment
Time frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Next day performance sa determined by Digit Symbol Substitution Test (DSST)
Time frame: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Subjective Sleep Onset and Maintenance as determined by Subjective Sleep Questionnaire (SSQ)
Time frame: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Wake time during sleep (WTDS) as determined by PSG assessment
Time frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Wake time after sleep (WTAS) as determined by PSG assessment
Time frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Percentages of Stage 1 Sleep, Stage 2 Sleep, Stage 3+4 Sleep, Stage REM Sleep as determined by PSG assessment
Time frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23
Restorative sleep as determined by Restorative Sleep Questionnaire Daily (RSQ D)
Time frame: Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD 0200390 in people with Insomnia, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wake After Sleep Onset (WASO) as determined by PSG assessment (time frame: Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2009.